Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,470
- 试验地点
- 3
- 主要终点
- Diagnosis of pneumonia
研究概览
简要总结
The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease (URTD).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 29 Days 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant or child aged greater than 29 days up to and including their 12th birthday (infant and children pediatric subgroups as defined in Guidance for Industry and Food and Drug Administration Staff: Premarket Assessment of Pediatric Medical Devices dated March 24, 2014)
- •Presenting to the study site (an outpatient facility, an urgent care center, an Emergency Department, or inpatient ward within 24 hours of admission) with current signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, nasal congestion/rhinorrhea, abnormal lung sounds on exam or cyanosis/hypoxemia.
- •Onset of symptoms within past 14 days
- •Outpatient or inpatient within 24 hours of admission
- •Coughing spontaneously or able to cough voluntarily
排除标准
- •Lack of a signed consent form from parent or legal guardian
- •Lack of signed assent form for children aged 7 years or older who, in the opinion of the investigator, is able to provide assent based on their age, maturity or psychological state.
- •Need for mechanical ventilatory support ((including invasive, CPAP, or BiPAP)) or high flow nasal cannula
- •History of structural airways abnormalities, tracheobronchomalacia, or vocal cord abnormalities (e.g. laryngomalacia, tracheomalacia, or bronchomalacia)
- •Any medical contraindication to voluntary cough, including the following (only enroll if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month
- •Too medically unstable to participate in study per treating clinician
- •Subject previously enrolled in SMARTCOUGH-C-2 study
- •Tracheostomy present or tube placed
结局指标
主要结局
Diagnosis of pneumonia
时间窗: 6 months
Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with (1) World Health Organization (WHO) Primary Endpoint Pneumonia (PEP) plus clinical pneumonia, (2) WHO PEP or Other Infiltrate plus clinical pneumonia, (3) Clinical pneumonia alone
Diagnosis of other childhood respiratory diseases
时间窗: 6 months
Positive percent agreement and negative percent agreement to diagnose and rule out: lower respiratory tract disease (i.e. respiratory condition occurring below the level of the larynx), viral lower respiratory tract infection, bronchiolitis, asthma/reactive airways disease, upper respiratory tract disease, and croup.
次要结局
未报告次要终点